上海华理生物医药股份有限公司

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上海华理生物医药股份有限公司  

从实验室到商业化，提供一致、可控的原料药工艺开发与供应解决方案 From Lab to Commercialization: Consistent, Controllable Process Development and Supply Solutions for API Manufacturing 上海华理生物医药股份有限公司是一家以研发为驱动的医药原料供应商，专注于含氟分子砌块、医药中间体及原料药的开发与供应。 Shanghai ECUST Biomedicine Co., Ltd. is a research-driven supplier of pharmaceutical ingredients, specializing in the development and supply of fluorinated building blocks, pharmaceutical intermediates, and active pharmaceutical ingredients (APIs). 依托自主实验室，我们具备毫克至公斤级的小批量定制合成能力，支持药物研发早期阶段的快速样品交付。同时，我们与符合GMP规范的规模化生产工厂建立了深度战略合作，可承接吨级以上的商业化订单。从实验室工艺开发到工业化生产，严格执行同一套工艺标准与质量控制体系，确保放大过程中的一致性、合规性与可追溯性。 Leveraging our in-house R&D laboratory, we offer custom synthesis capabilities from milligram to kilogram scale, supporting rapid sample delivery during early-stage drug discovery. In parallel, we have established deep strategic partnerships with GMP-compliant manufacturing facilities to fulfill commercial-scale orders of metric tons and above. From laboratory process development to industrial production, we adhere to the same set of process standards and quality control systems, ensuring consistency, compliance, and traceability throughout scale-up. 公司拥有系统的药物合成工艺开发与质量研究能力，可提供从路线设计、条件优化到杂质谱分析、方法学验证的全流程技术支持。我们擅长无水无氧反应（如格氏反应）、超低温反应（可达-70℃）、高温反应、氰化反应、高压催化氢化反应、化学动力学拆分、含氟砌块设计及合成等特殊单元反应。可有效支持药物研发及生产企业优化合成路线、降低工艺成本、提升杂质控制水平，提供更具技术竞争力的工艺与质控方案。 The company possesses systematic expertise in drug synthesis process development and quality research, providing full technical support including route design, process optimization, impurity profiling, and analytical met